NMT Medical pushes up StarFlex trial

September 16, 2009 by MassDevice staff

The Boston-based cardiac implant maker plans to begin analyzing trial data in April 2010, ahead of its fall target date, potentially setting the stage for a PMA application to the FDA in after the third quarter next year.

NMT Medical Inc. plans to begin analyzing the data from a clinical trial of its StarFlex cardiac implant ahead of schedule.

The Boston-based device maker said it will begin analyzing data from the CLOSURE I clinical trial of its StarFlex implant in April of next year, ahead of its fall 2010 target date.

The study aims to determine whether the device can help prevent stroke or ischemia from patent foramen ovale, a defect in the septum separating the heart's atrial chambers.

By April next year, more than 99 percent of all patient follow-up months will be done and about 95 percent of patients will be through the two-year follow-up period.

Based on those criteria, NMT is following a recommendation by the study's executive committee that it accelerate the data analysis.

And, if the results materialize as anticipated during the third quarter of 2010 and are positive, the company will be set to submit a pre-market approval application to the Food & Drug Administration for a stroke/TIA indication for the device.

NMT posted second-quarter revenues of $3.2 million, down from the $4.5 million recorded in the year-ago quarter. Net losses for the quarter reached $3.8 million, compared with a $5.6 million during the 2008 second quarter.